Friday, May 29, 2009

A review in NEJM emphasizes the basics (taking care of the ABC’s and administration of 100% oxygen in the field) then addresses the controversy surrounding hyperbaric oxygen administration. Although research results are mixed a single trial, which is the best quality study available, indicates benefit. The editorial writer concludes that one should consider hyperbaric therapy for patients with acute CO poisoning.

Despite mixed results in studies the guidelines from the Undersea and Hyperbaric Medical Society are liberal in their recommendations for hyperbaric treatment:

UptoDate has similar recommendations and suggests cutoffs for carboxyhemoglobin levels above which hyperbaric treatment should be administered. Their suggestion is 25%, or 20% in pregnancy.

A policy statement from the American College of Emergency Physicians cites the conflicting evidence, notes that hyperbaric oxygen is a therapeutic option, and comes short of a definitive recommendation.

Tick paralysis (TP), a response to the neurotoxic effects of the salivary secretions produced by attached hard ticks (Ixodidae), is a syndrome that mimics a large number of better known neurological disorders….Recognition and timely removal of the tick usually leads to complete resolution of symptoms, whereas continued feeding can lead to respiratory arrest and death.

The Medscape article contains a world of information on the practical aspects of management.

The new report is "right on," says Lucian Leape, MD, adjunct professor of health policy at Harvard School of Public Health and longtime patient safety advocate. The lack of progress in implementing the IOM recommendations, he says, ''is an immense public policy failure."

The report makes two claims. The first, that we’ve implemented virtually none of the IOM’s recommendations, appears to be true. It’s easy enough to verify, and the reasons for this non-implementation deserve scrutiny. The second claim, that around 100,000 patients “still” die as a result of medical “errors”, is little more than the revival of an old canard.

First some background. The Medscape report notes:

In 1999, the Institute of Medicine (IOM) issued an alarming report titled "To Err is Human," detailing the toll of preventable medical errors in the U.S; it estimated that up to 98,000 Americans die annually from them.

The idea of “98,000 Americans killed in hospitals annually” became dogma as a result of obfuscation by the IOM and its media accomplices. First the Institute of Medicine distorted the original research in its report To Err is Human. In a NEJM Sounding Board piece the author of that research criticized the IOM report and said the claim of 98,000 deaths due to medical error was distorted and unwarranted by the research findings. The claim later became entrenched in American medical folklore by the media frenzy which followed.

The new Safe Patient Project report restates the popular myth of 98,000 lethal medical mistakes annually, then claims that the number is at least as high today with no good data to back up the claim. Although the media will trumpet their “findings” of at least 100,000 fatal medical errors yearly the writers of the report themselves admit they don’t have good data (italics mine):

Based on our review of the scant evidence, we believe that preventable medical harm still accounts for more than 100,000 deaths each year a million lives over the past decade.

So how far have we really come during the decade since “To Err is Human?” First we must be honest about the fact that we really don’t know how many patients die as a result of medical error. For what it’s worth, though, we can agree that virtually none of the IOM’s recommendations have been implemented. Let’s consider why. The entire IOM safety program was premised on there being a culture of transparency. The move toward transparency, though, never had a chance. From the moment the patient safety conversation was framed in terms of errors all good intentions of transparency were sabotaged by a rapidly developing culture of blame. You will never have transparency in a culture of blame. The authors of the Safe Patient Project report, who should be experts on patient safety, don’t even get it. Astonishingly, they want a stronger culture of blame and think tort reform is responsible for the lack of progress:

With a civil justice system weakened by limited compensation to harmed patients and inadequate oversight of health care, public reporting of preventable medical harm is today perhaps the only effective accountability measure we have.

The media frenzy following the IOM report resulted in increasingly careless use of the term “medical error,” such that many unavoidable events came to be characterized as errors. Worse, Medicare’s never event policy resulted in some unavoidable outcomes being administratively defined as error. Now, as a result, we are faced with a developing new legal standard in which such events are considered prima facie evidence of someone’s negligence. Thus the culture of blame is not only entrenched in medical culture but is becoming codified in our tort system. This will not only undo much of what has been accomplished by tort reform but also set the cause of transparency back, perhaps for decades.

I agree with the authors of the Safe Patient Project report that, after a decade, the patient safety movement is a failure, though not for the reasons they state. Although advances in medicine have improved patient outcomes over time the patient safety movement, in its attempt to effect beneficial system changes, has been worse than a failure. It has backfired.

The danger…is that many hospital administrators see hospitalists as valuable…as utilities.

I am a nurse employed by a large for-profit hospital corporation, where ill patients requiring complex care are reduced to standardizable, predictable units of production with one-size-fits-all solutions. Business concepts of efficiencies and productivity determine health care priorities. Managing costs rather than managing care, when it comes to dealing with the complex care of ill patients, deteriorating working conditions,and poor patient care, trump compassion and quality of care.

Where I work, hospitalists are valued by administration as utilities to managing costsrather than as valuable assets to providing high quality care to patients.

Thursday, May 21, 2009

This is the most controversial portion of her talk, where she expresses views that have been misappropriated as opposition to comparative effectiveness research. But listen carefully and note that she does not express opposition to head-to-head trials or any other means of comparing treatments. What she does express is skepticism regarding the current administration’s agenda behind the research. She goes on to expose a philosophical bent towards rationing, particularly in the care of the elderly, among key administration health policy players now in a position to put their beliefs into practice by design tweaking and spinning the research.

This adverse effect of benzodiazepine sedation seems to be related to dosage, as do various adverse effects unique to other sedative agents, highlighting the need to minimize sedative doses. I wonder if we would be better off using combinations or agents or alternating agents.

Wednesday, May 20, 2009

Betsy McCaughey and others have been ridiculed for their skepticism about the health care provisions hidden in the stimulus bill. What does she really have to say? As time permits I’ll be looking at some primary source material and posting my thoughts. For now, here’s part 1 of one of her recent talks.

In this section of her talk she mentions treatment protocols embedded in EMRs. She’s taken a lot of heat for that by those who have misinterpreted her remarks. Here she comes short of saying the government will use the national EMR to force doctors into compliance with certain treatment protocols. What she says instead is that the stimulus bill, with its vague language and the discretionary leeway it gives policymakers, empowers them to do that.

I actually think decision support embedded in the EMR, as I noted here, is a good idea, but I’m skeptical of any such “support” that comes from the government.

Health care policy discussions these days share a common theme: health care expenditures in the U.S. are excessive; if doctors would adhere to research evidence (or if they had more research findings to adhere to) costs would go down, right? Wrong, according to the best data we have on quality metrics, published in NEJM:

We also classified indicators according to the problem with quality that was deemed most likely to occur, and we found greater problems with underuse (46.3 percent of participants did not receive recommended care [95 percent confidence interval, 45.8 to 46.8]) than with overuse (11.3 percent of participants received care that was not recommended and was potentially harmful [95 percent confidence interval, 10.2 to 12.4]).

According to this landmark study, with recommendations derived from research as the benchmark, doctors underutilize far more than they overutilize. It’ll take some really creative design tweaking by government policy makers to produce research findings to drive their agenda of lowering costs.

In addition to Obama’s intelligence and forthrightness (with the exception of one dollop of purposeful disingenuousness, which I’ll get to later), I was floored by his personal knowledge of and passion for healthcare issues – particularly the increasingly contentious comparative effectiveness question…

The interview covered multiple aspects of economic policy. Although a superficial reading suggested a leader who’s knowledgeable, articulate and has some good ideas there was this uneasy feeling about an agenda to redistribute wealth somewhere between the lines. But today I’ll focus on the health care discussion, one of six sections of the interview.

First a general observation. Nowhere in the interview did Obama say he intended to enact anything. Instead he talked about a conversation (he used the word four times). Now that’s the disingenuousness Bob was talking about. With a congress poised to give him virtually anything he wants (oh, for the days of gridlock) and all that passion for health issues we can be sure it’ll be more than a conversation.

Before I get to the meat of the health care discussion, wasteful spending and comparative effectiveness research, I have to say I was mildly impressed by his balanced view on medical consumerism:

I have always said, though, that we should not overstate the degree to which consumers rather than doctors are going to be driving treatment, because, I just speak from my own experience, I’m a pretty-well-educated layperson when it comes to medical care; I know how to ask good questions of my doctor. But ultimately, he’s the guy with the medical degree. So, if he tells me, You know what, you’ve got such-and-such and you need to take such-and-such, I don’t go around arguing with him or go online to see if I can find a better opinion than his.

And so, in that sense, there’s always going to be an asymmetry of information between patient and provider.

How about that? Our President thinks a little paternalism is a good thing! (Contrast that with Don Berwick’s extreme idea of patient centered care). That paternalism, of course, has a dark side when its responsibility shifts from the individual doctor to the government. Note that Obama went on to say:

And part of what I think government can do effectively is to be an honest broker in assessing and evaluating treatment options.

And that brings us to the matter of wasteful spending and comparative effectiveness research. I’ve recently blogged extensively about the dishonesty in the discussions about CER as well as the massive conflict of interest in the government’s plan for implementation. Concerning wasteful spending on healthcare Obama said this:

And so if it turns out that doctors in Florida are spending 25 percent more on treating their patients as doctors in Minnesota, and the doctors in Minnesota are getting outcomes that are just as good — then us going down to Florida and pointing out that this is how folks in Minnesota are doing it and they seem to be getting pretty good outcomes, and are there particular reasons why you’re doing what you’re doing? — I think that conversation will ultimately yield some significant savings and some significant benefits.

The premise behind that statement and other comments President Obama made in the interview---that doctors really want to do what’s best for the individual patient and the medical commons---is where policy discussions should start. But does he really mean it? Wachter once again weighed in with a more cynical view of our professionalism:

But notice Obama the Politician at work. He knows full well that simply providing doctors in Florida information about how Minnesota docs practice ain’t gonna do the trick. (“Oh, really. Sure, now that I know about how they do things in Minneapolis, I’ll cut my cath volume by 30%!” I don’t think so.)

What’s interesting is that no one in this discussion (except for one of Bob’s commenters) mentioned the malpractice crisis as a cause of excessive spending, or of variation among regions. It just so happens that according to a recent Pacific Research Institute report Florida ranks worst of all 50 states in terms of malpractice litigation risks! Hmmm….

The agenda for more and more government control over health care is fueled by Dartmouth Atlas data which demonstrate regional variations in spending with no correlation between spending and quality or outcomes. I would like to see some Dartmouth maps relating spending by region to malpractice climates (read Kevin’s USA Today op-ed about how defensive medicine and the fear of being sued drives unnecessary spending), obesity, crime or tobacco use. Those are embedded cultural factors driving practice variation and need to be addressed at their sources. But practice variations data have been used to politicize comparative effectiveness research. If the problem, as the boosters of government sponsored CER contend, is that doctors don’t have enough data to make rational clinical decisions, then what must follow is some absurd notion that docs in some regions as opposed to docs in other regions just don’t have research findings to help make decisions. (And if the cause of practice variation is greed and self interest does that mean some geographic regions breed better ethics and more altruism than others?). The use of Dartmouth Atlas data to support an agenda for more government control over health care (oh, for the days of gridlock) is simplistic.

There’s no government fix for health care. As I said before I start with the premise that most doctors really want to practice efficient medicine based on the best evidence, but are beset with barriers. Public policy should start with that premise by addressing those barriers and giving doctors tools, not rules to put evidence into practice. That might lead to more efficient practice in all areas of the country.

Tuesday, May 19, 2009

Researchers at the University of Calgary report on an interview instrument to evaluate candidates’ “noncognitive attributes” for medical school. The instrument uses vignettes presented to the interviewee concerning moral and ethical dilemmas, and is purported to reflect dimensions of altruism, dutifulness and morality.

A look at the Student Doctor Network Interview Feedback postings indicates that a lot of schools are doing this although perhaps in a less systematic fashion. It also demonstrates considerable coaching among premeds in anticipating the questions and preparing for the “right” answers.

Monday, May 18, 2009

Dr. Rich’s latest post on CER eloquently reinforces some of my points. Let’s start with the premise that bias in research isn’t exclusive to industry funded research. Dr. Rich writes:

While in laboratory research the elimination of bias is always a challenging endeavor, DrRich believes that in clinical research it is an ultimately futile endeavor.

That’s because we’re all biased and conflicted. The loudest voices in this debate, the pharmascolds, are not honest about that fact.

He goes on:

And for this reason, anyone claiming to have performed unbiased clinical research is either blowing smoke up your nether regions, or is too ignorant about the realities of clinical research to be allowed to perform it.

A little later in the post he says:

The sad truth is that the results of RCTs are invariably dependent on the bias built into their design, and even if internally they are statistically legitimate, they can often send us down the wrong path.

More important though is the fact that compared to placebo controlled trials this bias is magnified in CER (which, before it was given the catchy and politically charged new name, is what we used to call head-to-head trials). The reason for this is, as I explained with numerous examples, is that there are more abundant opportunities to tweak the design of head-to-head trials than of placebo controlled trials. So the bias inherent in all clinical research finds greater opportunity in CER.

He goes on to note:

Those who design RCTs (the smart ones, at least) know this. Like smart trial attorneys, they know the answer before they ever dare to ask the question. So they tailor their “question” in such a way as to yield the answer they want to get.

This is particularly true of the new government program of CER. In a recent post I cited many statements by the promoters of CER which illustrate the fact that they already know what the “research” will show: it will favor cheaper treatments.

Dr. Rich describes how bias can creep into design:

So, for instance, if you are a payer and want to limit the use of an expensive therapy, you design your RCT so that enrolled patients likely to respond to the therapy are diluted with a broad population of enrolled patients much less likely to respond, to assure that the average response of the whole population will be quite small. (In many instances the clinical characteristics of the likely responders and the likely non responders will be reasonably apparent.)

Among many other studies Dr. Rich might have been describing ALLHAT, a comparative effectiveness hypertension trial in which an ACE inhibitor could not, in the study design, be administered in a pharmacologically rational manner. Specifically, it could not be combined with diuretics or other medications known to produce a synergistic effect which, though a disadvantage in all patients, was previously known to be particularly adverse in African Americans, who made up 35% of the ALLHAT population. The deck was thus stacked in favor of thiazide diuretics.

But here’s the bomb in Dr. Rich’s post:

The apparently widespread notion that industry-sponsored research is invariably biased, while government-sponsored research is entirely objective - and that therefore, the only thing we need to assure accurate research is to have it all conducted by the government - is astoundingly naive.

At New York Hospital Queens, KPC-producing Klebsiella have become endemic. Thus, neutropenic patients with serious hospital-acquired infection receive a five-drug regimen to treat a wide variety of potential multiresistant pathogens. This consists of polymyxin B, vancomycin, rifampin, tigecycline, and a carbapenem.

In today’s tanking economy diabetic patients may have more trouble than ever affording their medications. Iatrogenic non-compliance results when patients can’t afford our prescriptions. In this Medscape video Anne Peters, MD offers tips on what we can do to trim the cost of our patients’ regimens without compromising treatment. Many oral diabetes agents, as well as stains and antihypertensives are generic, and don’t forget those generic insulins.

On March 20, the FDA approved a new indication for tigecycline intravenous infusion (Tygacil, Wyeth Pharmaceuticals, Inc), allowing its use for the treatment of community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumonia (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.

These approvals for specific pathogens don’t make a whole lot of sense because initial antibiotic selection is seldom possible on the basis of microbiologic data, but that’s the way the FDA works.

Given its excellent tissue penetration and anti-MRSA activity it’s certain to be used “off label” for MRSA pneumonia or suspected MRSA pneumonia although that role needs better definition. Vancomycin and linezolid remain the alternatives of choice for MRSA pneumonia although they leave much to be desired. A recent review of MRSA pneumonia in Current Opinion in Pulmonary Medicine said:

Tigecycline is a glycylcycline antimicrobial, a new analogue of tetracycline that has in-vitro activity against MRSA. It is bacteriostatic and rapidly distributed with extensive tissue penetration. The drug is approved for complicated intraabdominal infections and SSTIs. In-vitro data suggest that the drug was four-fold more potent than vancomycin and eight-fold more potent than linezolid against respiratory pathogens, including MRSA. Clinical data are needed to define its role in the treatment of CAP and HAP due to MRSA.

Right now, “there is no place that helps you sort through a specific option and how that compares to another,” said Dr. Carolyn M. Clancy, the director of the Agency for Healthcare Research and Quality.

Although the idea is totally false it’s been demagogued successfully into popular belief. The government proponents of CER want power over research and, worse, over the implementation of research findings into clinical practice.

Avron appears to be saying that the Government administrators are competent and unbiased enough to make life saving decisions. For those of us who have spent a few years in Washington, we know all too well that Washington is the last place you would want such a decision to be made. Why not have the professional societies do this. In many ways it is akin to medical licensing. Why not have the professionals that are performing the studies and treating the patients make the recommendations, and change them as needed. Imagine if HHS wrote Harrison's!

"An honest critique is nothing to fear," says an MPC contributor. "The problem arises when patients perceive that they have been offended and write scathing critiques. I find this hurtful and deceitful and not at all beneficial."

Now there’s a new twist. Doctors, unable to respond to the distorted posts, sue, or get them taken down, are resorting to some creative ways to participate in the game:

A few physicians even jest about starting a Website devoted to deadbeat patients. Others prefer to stuff the online ballot boxes. Quips an allergist, "Every anonymous review I've written on myself has been glowing." An anesthesiologist recommends that physicians have their patients fill out comment cards in the office that can later be posted on physician-ratings Websites. An emergency medicine physician says, "Dilute the negative comments by encouraging your satisfied patients to post their comments." An otolaryngologist remarks that his practice has gained numerous patients from positive online reviews. "We help patients get to the sites to write their reviews." This proactive approach has netted his practice 50 positive reviews for every negative one. "The bad ones are totally ignored since they look so petty."

Some physician-advocate sites, such as Medical Justice (www.medicaljustice.com), encourage physicians to silence their patients by what amounts to a gag order.

The most feared mechanisms of emerging gram negative resistance are ESBLs, AmpC beta lactamases and carbapenemases. From a systematic review of tigecycline for the treatment of these infections:

Twenty-six microbiological and 10 clinical studies were identified. Tigecycline was active against more than 99% of 1936 Escherichia coli isolates characterized by any of the above resistance patterns…

The degree of microbiological activity of tigecycline against 576 MDR Enterobacter spp. isolates was moderate. In clinical studies, 69.7% of the 33 reported patients treated with tigecycline achieved resolution of an infection caused by a carbapenem-resistant or ESBL-producing or MDR Enterobacteriaceae.

Conclusions: Tigecycline is microbiologically active against almost all of the ESBL or MDR E. coli isolates and the great majority of ESBL or MDR Klebsiella spp. isolates.

So it shows promise. It is likely to be combined with other agents in empiric use.

Tuesday, May 12, 2009

Evidence based medicine (EBM) was “launched” in 1992. The ensuing years have seen the design and appraisal of research become more systematic and disciplined. Moreover, the internet has revolutionized information retrieval. Has EBM matured in that time? Despite remarkable advances, practice variability remains high and the uptake of best evidence is disappointing---alarmingly low, in fact.

Boosters of Comparative Effectiveness Research (CER with CAPITAL letters, mind you) promote it as a means of aligning practice with best evidence. But if doctors are ignoring the research they already have in spades will government largesse to fund even more research help? It won’t unless, some argue, it’s coupled with bureaucratic muscle to compel doctors to adhere to some uniform standard. That concern, raised by many skeptics, has been ridiculed by the CER enthusiasts. Jerry Avorn wrote in his recent NEJM perspective piece:

As the stimulus bill was being debated in January and February, the opposition to CER found its voice in commentators who claimed that these studies will inevitably lead to government domination of the doctor–patient relationship, "cookbook medicine," andrationing.

and

On January 23, Representative Tom Price (R-GA), a physician, sent out an "alert" through the Republican Study Committee, falsely warning that the CER legislation would create "a permanent government rationing board prescribing care instead of doctors and patients." The true intent of the CER provision, Price warned, was "to enable the government to ration care" (emphases in original).

He went on---

The assault took on a more Orwellian tone 10 days later when Betsy McCaughey, a former lieutenant governor of New York, linked funding for CER with the stimulus bill's provisions supporting the use of electronic medical records. She warned that the inclusion of both initiatives was designed to enable electronic monitoring of individual patient-care decisions by the federal government and punishment of clinicians who fail to comply with imminent rationing guidelines.4 The radio talk-show host Rush Limbaugh then disseminated this message to millions of listeners, warning that once the stimulus bill "computerizes everybody's health record," a new federal bureaucracy "will monitor treatments to make sure your doctor is doing what the federal government deems appropriate."5

This avalanche of nonfacts did not succeed in derailing the stimulus bill or its CER funding.

So Avorn, along with other advocates for the government program of CER, portrays the skeptics’ argument as a ridiculous straw man.

To me, NICE’s experience shows that rationing based on cost-effectiveness can be done, but we can count on it being about ten times harder in the United States (with our fragmented healthcare system, our sensationalist media, our hypertrophied legal system, and our tradition of individual benefit trumping the Good of the Commons) than it has been in the UK.

If that’s not a plain enough statement of the agenda read on to the end of the post:

We simply must find ways to drive the system to produce the highest quality, safest care at the lowest cost, and we need to drag the self-interested laggards along, kicking and screaming if need be. Comparative effectiveness research is the scientific scaffolding for this revolution, so bring it on.

As much as we like to blame the politicos, the drug and device companies, and the MBAs, the AHCPR fiasco demonstrated that physicians are every bit as capable of self-interested venality as any other group.

That’s Bob’s view. What about the government policy makers who have promoted CER? Bob notes that White House budget director Peter Orszag, who helped push the $1.1 billion program into existence, is a Dartmouth Atlas aficionado. The Dartmouth Atlas project is frequently trotted out and used as ammo for those advocating more government control of health care. As Dr. Rich recently pointed out Orszag has been evasive about the agenda:

The ambiguity of CER (as compared to cer) was made clear recently when Peter Orszag testified on behalf of the administration before the Senate Finance Committee. When queried by skeptical Republicans on the ultimate goal of the proposed CER board, Mr. Orszag was evasive. Specifically, when asked by Senator Kyle (R-Arizona) whether the CER board would be empowered to make decisions on which medical services will be reimbursed, Mr. Orszag finally replied, “Not at this point,” a reply whichdid not alleviate the suspicions of the minority party.

That’s Orszag in public. His statements in the Congressional Budget Office paper on CER are more telling and make it abundantly clear that government sponsored CER is likely to be agenda-driven “research” as I noted here.

But back to Bob’s post---mark his words well: …and we need to drag the self-interested laggards along, kicking and screaming if need be. Comparative effectiveness research is the scientific scaffolding for this revolution, so bring it on.

Telling indeed. How can that approach possibly work? It rubs me the wrong way because I’m libertarian (well, libertarian as far as my Christian faith will allow me to be, as Stephen Mansfield recently put it).

Is the self-interested venality of physicians, as Bob calls it, the major barrier? Well, we physicians are conflicted, but EBM mavens Sharon Straus and Brian Haynes, writing recently in CMAJ, take a different view of the problem. They start with the premise that physicians want to practice according to best evidence but are beset with access barriers. Let’s examine the history of those barriers.

In the early days of EBM if you wanted to search for best evidence you might have found yourself in the archives of the paper library thumbing through the Index Medicus. A search on a single clinical question might have taken an entire weekend. Not very conducive to decision making at the point of care. The first web browser wasn’t launched until the year after EBM was launched, and it was considerable time after that before the web was ready for prime time. Until then if you wanted to be wired you had to put considerable work into it, as I found out from personal experience. (BTW: although Al Gore didn’t invent the Internet he was instrumental in helping get funding for development of the first browser).

After the Internet matured and PubMed came along EBM teaching outlined several steps: Formulate a concise clinical question, translate it into a set of search terms, conduct the search (usually in PubMed), cull the results, then critically appraise the relevant articles. Finally, integrate the answer thus found with clinical judgment and patient preferences. Although PubMed enabled searching at lightning speed compared to the paper library the process, as I noted early in my blogging career, was still prohibitively time consuming.

That’s what Straus and Haynes address. An editorial on EBM in a recent issue of American Family Physician said:

There is a rich body of literature advising physicians on how to ask and answer questions. Too often, though, it has encouraged physicians to focus on PubMed searches and the original research literature, a time–consuming and sometimes frustrating process. This is not unlike trying to encourage people to use e–mail and the Internet by teaching them how to write Javascript code, or encouraging people to bake bread but forcing them to grow their own wheat. Hardly a recipe for success!

Exaggerated but apt. The answer, the editorial suggests, lies in “secondary sources.” Because these sources have already done the steps of primary searching, culling and critical appraisal they offer short cuts to clinicians. Straus and Haynes note that these sources are a work in progress and that we have a ways to go in reducing the barriers to evidence uptake. Embedding information sources into electronic medical records offers hope of more effective use. The best of the best academic medical centers have learned how to embed them into their entire electronic infrastructure without being intrusive. The motto at Vanderbilt, where a model system is in place, is “tools, not rules.”

So which is the more constructive philosophy? More and better tools or dragging doctors into compliance “kicking and screaming”? You know my vote. Furthermore, as someone recently said, (sorry, I’ve misplaced the primary source for proper attribution) I do not want a panel of government policy makers writing the next edition of Harrison’s.

Dr. Bobbs has written a skeptical post on EMRs, citing an AAFP blog post and the Medical Economics article I referenced here.

Although the EMR is widely touted as an important part of the solution for much of what ails health care, evidence and experience suggest it ain’t so, at least in its present state of development. The AAFP post cites a recent WSJ article by Groopman and Hartzband. It opens:

Last week, President Barack Obama convened a health-care summit in Washington to identify programs that would improve quality and restrain burgeoning costs. He stated that all his policies would be based on rigorous scientific evidence of benefit. The flagship proposal presented by the president at this gathering was the national adoption of electronic medical records -- a computer-based system that would contain every patient's clinical history, laboratory results, and treatments. This, he said, would save some $80 billion a year, safeguard against medical errors, reduce malpractice lawsuits, and greatly facilitate both preventive care and ongoing therapy of the chronically ill.

That’s generous serving of Obama Kook-Aid.

The article deserves to be read in its entirety. The authors go on to review the evidence:

A study of orthopedic surgeons, comparing handheld PDA electronic records to paper records, showed an increase in wrong and redundant diagnoses using the computer -- 48 compared to seven in the paper-based cohort…

A 2008 study published in Circulation, a premier cardiology journal, assessed theinfluence of electronic medical records on the quality of care of more than 15,000 patients with heart failure. It concluded that "current use of electronic health records results in little improvement in the quality of heart failure care compared with paper-based systems." Similarly, researchers from the Brigham and Women's Hospital and Harvard Medical School, with colleagues from Stanford University, published an analysis in 2007 of some 1.8 billion ambulatory care visits. These experts concluded, "As implemented, electronic health records were not associated with better quality ambulatory care." And just this past January, a group of Canadian researchers reviewed more than 3,700 published papers on the use of electronic medical records in primary care delivered in seven countries. They found no solid evidence of either benefits or drawbacks accruing to patients. This gap in knowledge, they concluded, "should be of concern to adopters, payers, and jurisdictions."

It’s worse than a gap in knowledge. It’s a complete lack of supporting evidence. Why, then, the rush for adoption?

Dr. Bobbs quotes from the Medical Economics Article:

In April 2008, a study published in the New England Journal of Medicine reported similar problems, pointing out that “Notes that are meant to be focused and selective have become voluminous and templated, distracting from the key cognitive work of providing care. Such charts may satisfy the demands of third-party payers, but they are the product of a word processor, not of physicians’ thoughtful review and analysis. They may be ‘efficient’ for the purpose of documentation but not for creative clinical thinking.”

The study also reported an example of the consequences of these problems: “A colleague at a major cancer center that recently switched to electronic medical records said that chart review during rounds has become nearly worthless. He bemoaned the vain search through meaningless repetition in multiple notes for the single line that represented a new development . . .

That came from this NEJM perspective piece by Groopman and Hartzband. I think “pimp my note" may be appropriate here to refer to electronically generated documentation that looks fancy and is long on text but devoid of substance. (In reference to the MTV show Pimp My Ride in which a car in poor condition gets a fancy make over which is mainly cosmetic, with little attention to the engine and other essentials).

Monday, May 11, 2009

It’s been over 16 years since the notion of EBM was popularized. You’d think in those 16 years we’d have come a long way. What once took an entire afternoon to find in the archives of a traditional print library (remember the Index Medicus?) can now be accessed in mere moments on line. Yet, the penetration of best evidence into clinical practice remains low, ranging from 10% to 50% in surveys. In spite of all the progress we’ve made there remain barriers.

In the February 15 installment of American Family Physician’s series on this topic Mark H. Ebell, MD, MS discusses some of these barriers. One of the most important barriers, he says, in spite of the improved speed that internet technology has delivered, is still time. Filtered resources (secondary sources) help save time by removing from the end user the steps of searching and critical appraisal. That’s a mixed blessing. In some situations there’s no substitute for searching and critically appraising the primary sources. Over reliance on secondary sources may lead to a loss of these skills. Secondary sources vary in quality and some are very expensive. It’s a work in progress.

Some of the barriers, Ebell points out, are cultural. One cultural barrier he didn’t mention is that of patients’ perceptions (or misperceptions) about searching for answers at the point of care. Some patients admire and respect the doctor who goes to the trouble to look up answers. Others, thinking that doctors should “know it all”, may look askance. Doctors should be concerned about patients’ perceptions. Should they look up answers in front of the patient or should they leave the room?

Perhaps the ultimate advance to help improve penetration of evidence into practice is the embedding of best evidence pathways into computerized physician order entry systems. This technology is in its infancy.

A major downside to all these advances is that they de-emphasize background reading, pathophysiologic rationale, critical appraisal and judgment. Sixteen years after the launch of the EBM movement our biggest challenge moving forward is to increase the application of EBM to everyday practice without diminishing the physician’s role.

OASIS-5 showed fondaparinux (Arixtra) to be non-inferior in efficacy to enoxaparin (Lovenox) and to be associated with a decreased risk of bleeding in the treatment of unstable angina and NSTEMI. A new study in the American Heart Journal confirms these observations.

Fondaparinux has some unique risks but seems to cause less bleeding when used in the treatment of ACS. The findings cannot be extrapolated to the treatment VTE, in which higher doses of fondaparinux are used.

Sunday, May 10, 2009

The greater ease, compared to older insulins, in the implementation of basal/bolus regimens, is appealing. According to this meta-analysis, though, the benefits in terms of HbA1C levels were modest and of questionable clinical significance.

This analysis in the same issue of CMAJ looked at cost effectiveness and found that among short and long acting insulin analogues for type 1 and type 2 diabetes only the short acting analogues for type 1 diabetes were cost effective.

· The improved glycemic control, reduced risk of hypoglycemia and improved quality of life achieved with insulin analogues versus conventional insulins are at best minor and of clinically debatable relevance.· Insulin analogues should be reserved for use in selected patients, such as those with nocturnal hypoglycemia.· Efforts should be focused on offering structured educational programs to help patients manage their diabetes and improve glycemic control.

Many patients receive their initial diagnosis of diabetes during hospitalization. Basal/bolus regimens are started in such patients in order to maintain inpatient glycemic control. Protocols and order sets for glycemic control tend to favor insulin analogues. Newly diagnosed diabetics are often discharged on insulin analogues as a continuation of their hospital regimens, and because basal/bolus treatment is easier to understand and teach using analogues. The down side is that for patients with limited financial resources such a regimen may be a recipe for “noncompliance.”

These papers will cause me to rethink my discharge planning for newly diagnosed diabetics, particularly those with limited finances.

Friday, May 08, 2009

In issue 1 of 2009 the journal American Family Physician launched a series on the application of evidence based medicine: how to put best evidence into practice. (I don’t know why I bothered to link to the issue. In a reversal of today’s trend towards open access publication AFP has recently gone from open access to controlled access. Worse yet, you can’t even view the table of contents on line, let alone the abstracts. You can access the content if you are a member of AAFP, you have your own subscription, you or your hospital library has access to the MD Consult Core Collection or you get your own “throw away” copy in the mail).

Traditional teaching on EBM held that doctors should do PubMed searches to find answers to clinical questions. Because PubMed is cumbersome and time consuming for unskilled users, recent trends favor filtered resources or, as the writer of the introductory editorial calls them, secondary literature:

There is a rich body of literature advising physicians on how to ask and answer questions. Too often, though, it has encouraged physicians to focus on PubMed searches and the original research literature, a time–consuming and sometimes frustrating process. This is not unlike trying to encourage people to use e–mail and the Internet by teaching them how to write Javascript code, or encouraging people to bake bread but forcing them to grow their own wheat. Hardly a recipe for success!

Family physicians are busier than ever and have limited time to keep current with the literature. Reading lengthy and detailed original research studies is hardly the best use of that time. Practicing physicians, and even most academic physicians, do not have the training or time to critically appraise all of the articles needed to answer clinical questions or stay current.

I propose a different skill set that prioritizes making the practicing family physician an informed consumer of the secondary literature (e.g., evidence–based guidelines, systematic reviews, critical appraisals, validated decision–support tools).

I only partially agree. While secondary sources are indispensable, there are situations where there’s no substitute for the primary source. And while some secondary sources like UptoDate have the advantage of greater speed, PubMed can be used very efficiently with a little training and practice.

While this series is directed toward family physicians the information should be useful to general internists and hospitalists as well. If time constraints and lack of computer searching skills are barriers to the application of EBM this series should help. I’ll be commenting on various installments in future posts.

Most patients aged 90 years or older who received intravenous tPA for acute ischemic stroke had poor 30-day functional outcomes or died. Intravenous tPA treatment in this age group does not improve the outcome of ischemic stroke.

Thursday, May 07, 2009

The first piece, by Alan M. Garber, M.D., Ph.D., and Sean R. Tunis, M.D., addresses concerns by some groups that CER could impede the progress of individualized medicine if it drives a one size fits all approach. I view genomic medicine the way I view the electronic medical record. I believe it is the wave of the future but it may be decades before the science matures enough for it to be clinically useful on a broad scale. I agree with the authors that it’s difficult to know the impact of genomic medicine in any given time frame and even more difficult to know the impact of CER on genomic medicine. The Partnership to Improve Patient Care (PIPC), cited by the authors, expresses concern and skepticism but is not opposed to CER. Their web site says:

Used appropriately, comparative effectiveness research can play a valuable role in supporting good decision-making in health care. Moreover, improved quality is the best path to greater health care affordability….

While CER can play a positive role in improving patient care and health care delivery, it also can be misapplied in ways that unintentionally undermine patient access to care and physician-patient decision-making.

That's because comparative effectiveness research results typically are based on broad population averages that don't reflect the differences in needs of individual patients. Any research results need to be considered along with the broader body of evidence, the patient's individual needs and preferences, and the physician's clinicalexpertise.

That last statement (italics mine) merely urges the application of one of the fundamental principles of EBM (it’s straight out of David Sackett’s definition) to the findings of CER. The drug and device companies, who have been accused of opposing CER, are key players in PIPC. Clearly there’s no opposition to CER there.

The next piece, by Jerry Avorn, M.D., accuses skeptics of mounting a “vigorous and well-coordinated backlash” against CER. The problem is that the skeptics he cites, including Betsy McCaughey and Rush Limbaugh, were objecting to a hidden agenda in the stimulus package to increase government control over health care. That debate had nothing to do with CER. The whole piece was a straw man attack against legitimate skepticism towards the government’s plan for health care.

Aanand D. Naik, M.D., and Laura A. Petersen, M.D., M.P.H. discuss the problem of poor translation of evidence into practice and cite tools developed by the VA and AHRQ.

Finally, Daniel Carlat weighs in on the NEJM pieces and adds to the confusion in a post here by, again, suggesting there’s opposition to CER when in fact no such opposition exists. I have tried to read extensively about CER. In my reading, while I’ve encountered lively debate and opposition to Obama’s political agenda for health care I’ve yet to read any opposition to the pure notion of comparative effectiveness research. We all seem to agree it’s worthwhile.

First a link to Medscape’s Alert Center. It looks like a pretty good resource and features some interesting video blogs, most notably by John Bartlett, “the bomb” when it comes to emerging infectious diseases.

Now a word or two about the name. Apparently it’s now officially Influenza A H1N1. Swine flu was unsatisfactory because of the mistaken reference to the 1976 scare. Not the same bug. But Influenza A H1N1 seems even worse because not only the 1976 Swine flu but also the 1918 flu were H1N1 strains. In fact, Influenza A H1N1 signifies nothing. Why not a geographic name such as the three previous pandemics were given? The 1918 pandemic was called Spanish flu (which didn’t originate in Spain, BTW); the 1957 pandemic was named Asian flu; the 1968 pandemic was Hong Kong flu. H1N1 is not very informative but, as Dr. Bartlett suggests in one of his video blogs, at least it's politically correct.

Wednesday, May 06, 2009

First some definitions. Diastolic heart failure is the syndrome of heart failure due to impaired left ventricular filling in the context of a normal or near normal ejection fraction. Recently the term has been used interchangeably with “heart failure with preserved ejection fraction “(HFPEF). Such usage is not always appropriate, since some syndromes of HFPEF may be due to valvular dysfunction or systemic disease and need not involve diastolic dysfunction. (Personal observation: virtually all patients presenting to the hospital with acute decompensated heart failure have diastolic dysfunction and many have coexisting systolic dysfunction).

Key points from the article:

A vast body of evidence is available to guide treatment of systolic dysfunction. This is not true for diastolic dysfunction.

The evidence summary for pharmacologic therapies in the long term management of diastolic heart failure cited in the CMAJ review is shown here. Not impressive.

Guidelines for management, then, have been based largely on expert opinion and pathophysiologic rationale. They emphasize treatment of comorbidities and are summarized here. (Here’s an important JAMA paper emphasizing treatment of comorbidities in patients with HFPEF).

Though not exactly his ideological twin I agree with a lot of what Dr. Rich has to say and would consider myself among his camp of “classical liberals” (go and read carefully what he means by that term before you draw any conclusions). Dr. Rich’s writings reflect considerable insight and skepticism of simplistic ideas about medicine and health care. So I’m a little surprised to find him arguing for CER. My problem with this is that the need for such an argument presupposes opposition to CER. Dr. Rich writes:

And now, despite the fact that it will further alienate many of those who might otherwise be his conservative brethren, DrRich formally endorses Comparative Effectiveness Research (CER).

Conservatives, everyone must know by now, have taken a formal position on CER - they’re against it.

OK, stop. Where are these people, conservatives or those of any ilk, who have taken a position against CER? Dr. Rich cites groups who are skeptical and very concerned about the new political agenda for CER, not CER itself. The popular claim that there’s all this opposition to CER seems like a straw man argument to me.

If all these folks are against CER per se why their silence up to now, about the large amount of CER we’ve already had for decades? Those who claim that doctors have no research evidence upon which to draw to decide which treatments are best for their patients are either disingenuous, extremely cynical or just plain ignorant. (I don’t accuse Dr. Rich of taking that position, by the way).

Tuesday, May 05, 2009

I am a hospitalist and respect outpatient internists and family practitioners too much to consider myself as noble as them. But I am an internist and today, a pain management specialist paged me for a consult, I mean, comanagement, I mean, “take care of all the paperwork under the guise of controlling her already under control chronic illnesses”.

DB tells of another hospitalist who had to do some job hopping before he found professional satisfaction:

At Internal Medicine 2009, I ran into a former resident (from the 1980s when I was a program director.) I asked him about his career, and he told me of 15 years in private practice. He then left to become a hospitalist. He is finally happy in his 3rd hospitalist job.

These stories illustrate problems in the hospitalist movement which I’ve written about many times before. Here are the main points:

The original appeal of hospital medicine was that it was an opportunity for a clinician to focus on and ascend the unique clinical learning curve of hospital based internal medicine.

But because the role has not been carefully defined it is morphing into that of a jack-of-all-trades house doctor, a career few of us signed up for.

Uncritical enthusiasm for some nebulous notion of “comanagement” has blurred the boundaries of responsibility among hospitalists and other specialists and forced hospitalists into clinical encounters way beyond the scope of their training, pushing them out of their comfort zones and creating liability concerns.

Under the rubric of comanagement some hospitalist programs are being made to function as H&P and discharge planning services in which they perform the clerical scut work on surgical and subspecialty patients who have no need of their clinical expertise.

Hospitalists are increasingly coming to be viewed as administrative and business solutions more than clinicians. Not exactly what a candidate looks for in a career.

These factors may increase the risk of burnout, increase turnover in hospitalist programs and exacerbate the shortage in the work force.

Given this climate candidates who seek hospitalist jobs are increasingly likely to be short timers---docs who are moonlighting, are between jobs or are waiting to grab a fellowship.

DB goes on to say:

I have cautioned frequently in essays that the title does not define the job. I know of outstanding hospitalist jobs, and I know of jobs that represent semi-advanced resident positions.

Indeed. If you’re looking at hospitalist jobs ask tough questions. Find out what comanagement really means in the program you’re considering. In today’s market you can be picky. There are some good programs out there that will provide you with professional satisfaction. And there are some that will burn you out.

He concludes with:

Internists tend to say yes. We become the "least common denominator" for patient care - we get the patients who others "refuse." We are the nice guys and gals.

The best hospitalist programs set clear limits on their responsibilities. As hospital medicine evolves, it needs strong leadership based upon sound principles.

Does hospital medicine have the leadership it needs to address these issues? Hospital Medicine 2009, our national meeting, is about to start. We’ll see what our leaders have to say. If Hospital Medicine 2008 is any indication I’m not optimistic.

The laundry list of precautions to take starts with things which, if not evidence based, are at least plausible---get plenty of rest, stay away from hospitals and doctors’ offices if you can---then devolves into total woo: reflexology, tapping (especially those critical areas between certain chakras), homeopathy and various Yoga techniques.

(Digression: I have been smacked down, here and elsewhere, for my characterization of the religious and pseudoscientific underpinnings of Yoga with the rejoinder “Hey, lighten up, it’s just relaxation, stretching and balance exercise.” Almost all the explanations of Yoga I come across contain language like that above. It’s total woo).

The common thread in these remedies is the claim that they “boost the immune system.” Now, given that immunity exists on many levels, comprising diverse mechanisms and effector elements, any simple mention of an “immune system” can pretty nebulous. So what do the woosters really mean (assuming they even know what they mean) when they talk about the immune system? They must mean innate immunity rather than adaptive immunity because the former is the only type you could “boost” in a non-specific way absent vaccines or prior infection. But, given that it’s probably those innate immune mechanisms which caused the cytokine storm purported to make the 1918 pandemic so lethal in young healthy individuals I’m not sure I even want to boost my immune system in a non-specific manner!